Official Title
WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection
Brief Summary

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

Detailed Description

This Phase III trial will utilize four treatment strategies in non-critically ill hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin. We are primarily interested in the time to recovery. In addition to study medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4 weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily symptom surveys will be completed in conjunction with the study coordinators. On discharge participants will have the option to complete electronic symptom surveys or complete symptom surveys via telephone with study coordinator. In the event that the participant opts for electronic symptom surveys on discharge they will in addition receive a follow up call from a study coordination every 7 days during the initial 14 day period. In addition, failure to submit a symptom survey will prompt a study follow up call. Data from SOC will be collected from medical records.

Recruiting
Coronavirus Infection

Drug: Hydroxychloroquine Sulfate
anti-rheumatic drug (DMARD)
Hydroxychloroquine alone
Hydroxychloroquine plus azithromycin
Other Name: HYDROXYCHLOROQUINE Plaquenil

Drug: Azithromycin
Antibiotic
Chloroquine plus azithromycin
Hydroxychloroquine plus azithromycin
Other Name: COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin

Drug: Chloroquine Sulfate
Antimalarial
Chloroquine alone
Chloroquine plus azithromycin
Other Name: Aralen GENERIC NAME(S): Chloroquine Phosphate

Eligibility Criteria

Inclusion Criteria:

- Hospitalization for management of SARS CoV-2 infection

- Positive SARS CoV-2 test

- Age >=18 years

- Provision of informed consent

- Electrocardiogram (ECG) ≤48 hours prior to enrollment

- Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.

- If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study: - Condom (male or female) with or without spermicide - Diaphragm or cervical cap with spermicide - Intrauterine device (IUD) - Hormone-based contraceptive

Exclusion Criteria:

- Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin

- Current use hydroxychloroquine, chloroquine or azithromycin

- Concurrent use of another investigational agent

- Invasive mechanical ventilation

- Participants who have any severe and/or uncontrolled medical conditions such as: - unstable angina pectoris, - symptomatic congestive heart failure, - myocardial infarction, - cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG - pulmonary insufficiency, - epilepsy (interaction with chloroquine),

- Prior retinal eye disease

- Concurrent malignancy requiring chemotherapy

- Known Chronic Kidney disease, eGFRfive times the upper limit of normal ULN* - Bilirubin >five times the ULN* - Magnesium

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Washington University School of Medicine Infectious Disease Clinical Research Unit
Saint Louis, Missouri, 63110

Recruiting

Investigator: Michael Klebert, RN PhD
Contact: 314-454-0058
mklebert@wustl.edu

Investigator: Rachel Presti, MD PhD

Investigator: Jane O'Halloran, MD PhD

Investigator: Klebert Michael, RN PhD

Investigator: Adriana Rauseo Acevedo, MD

Investigator: Philip Spinella, MD

Investigator: Carlos Mejia Chew, RN

Investigator: Spec Andrej, MD

Washington University School of Medicine
Saint Louis, Missouri, 63110

Recruiting

Investigator: Michael Klebert, RN PhD
Contact: 314-747-1098
mklebert@wustl.edu

Investigator: Jane O'Hallorhan, MB BA PhD

Investigator: Rachel Presti, MD PhD

Contacts

Michael Klebert, RN PhD
314 747 1098
mklebert@wustl.edu

Jane O'Halloran, MD PhD
314-454-8354
janeaohalloran@wustl.edu

Jane O'Halloran, MD PhD
Principal Investigator
Washington University School of Medicine (ID-CRU)

Washington University School of Medicine
NCT Number
MeSH Terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Azithromycin
Hydroxychloroquine
Chloroquine
Chloroquine diphosphate